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Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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Substance-based medical devices encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according to rule 21 ("Devices composed of substances that are introduced via a body orifice or applied to the skin") of Annex VIII of the MDR . [2]
A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. The CE certificate and declaration of conformity can only be issued by a company located in the European Union. [1]
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Commission Implementing Regulation (EU) 2017/764 of 2 May 2017 approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed (Ovčí hrudkový syr — salašnícky (TSG)) Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0: Conversion program: Apache FOP Version 2.1 ...
Commission Implementing Regulation (EU) 2017/1945 of 19 June 2017 laying down implementing technical standards with regard to notifications by and to applicant and authorised investment firms according to Directive 2014/65/EU of the European Parliament and of the Council (Text with EEA relevance) Image title: Author: www.legislation.gov.uk ...
Commission Implementing Regulation (EU) 2017-725 of 24 April 2017 renewing the approval of the active substance mesotrione in accordance with Regulation (EC) No 1107-2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540-2011 (Text with EEA relevance)